Korean Journal of Biological Psychiatry (생물정신의학)

The Korean Society of Biological Psychiatry (대한생물정신의학회)
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Tolerability, Safety and Effectiveness of Paliperidone ER in Patients with Schizophrenia : A 24-Week Interim Analysis of the 48-Week Open-Label, Prospective, Switch Study

조현병 환자에서 Paliperidone Extended Release의 효능, 안전성 및 내약성 : 48주 개방형, 전향적 연구의 24주 중간 분석

  • Choi, You Ra (Department of Neuropsychiatry, Seoul National University College of Medicine, Seoul National University Hospital) ;
  • Jung, Dong Chung (Department of Neuropsychiatry, Seoul National University College of Medicine, Seoul National University Hospital) ;
  • Kim, Eun Young (Department of Neuropsychiatry, Seoul National University College of Medicine, Seoul National University Hospital) ;
  • Kim, Se Hyun (Institute of Human Behavioral Medicine, Medical Research Institute, Seoul National University) ;
  • Lee, Hyun Jeong (Department of Neuropsychiatry, Seoul National University College of Medicine, Seoul National University Hospital) ;
  • Lee, Nam Young (Department of Neuropsychiatry, Dongguk University International Hospital) ;
  • Chang, Sung Man (Department of Psychiatry, Kyungpook National University Hospital) ;
  • Shim, Joo Cheol (Department of Psychiatry, Inje University, Busan Paik Hospital) ;
  • Joo, Eun Jeong (Department of Neuropsychiatry, Eulji University School of Medicine, Eulji General Hospital) ;
  • Kim, Jae Jin (Department of Psychiatry, Yonsei University Gangnam Severance Hospital) ;
  • Lee, Sang Hyuk (Department of Psychiatry, CHA Bundang Medical Center) ;
  • Chung, Young Chul (Department of Psychiatry, Chonbuk National University Medical School, Chonbuk National University Hospital) ;
  • Kim, Yong Sik (Department of Neuropsychiatry, Seoul National University College of Medicine, Seoul National University Hospital) ;
  • Ahn, Yong Min (Department of Neuropsychiatry, Seoul National University College of Medicine, Seoul National University Hospital)
  • 최유라 (서울대학교 의과대학 서울대학교병원 정신건강의학교실) ;
  • 정동청 (서울대학교 의과대학 서울대학교병원 정신건강의학교실) ;
  • 김은영 (서울대학교 의과대학 서울대학교병원 정신건강의학교실) ;
  • 김세현 (서울대학교 의과대학 의학연구원 인간행동의학연구소) ;
  • 이현정 (서울대학교 의과대학 서울대학교병원 정신건강의학교실) ;
  • 이남영 (동국대학교 일산병원 정신건강의학과) ;
  • 장성만 (경북대학병원 정신건강의학과) ;
  • 심주철 (인제대학교 의과대학 부산백병원 정신건강의학교실) ;
  • 주은정 (을지대학교 의과대학 을지병원 정신건강의학교실) ;
  • 김재진 (연세대학교 강남세브란스병원 정신건강의학과) ;
  • 이상혁 (분당차병원 정신건강의학과) ;
  • 정영철 (전북대학교 의과대학 전북대학교병원 정신건강의학교실) ;
  • 김용식 (서울대학교 의과대학 서울대학교병원 정신건강의학교실) ;
  • 안용민 (서울대학교 의과대학 서울대학교병원 정신건강의학교실)
  • Received : 2013.01.24
  • Accepted : 2013.02.08
  • Published : 2013.02.28
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Abstract

Objectives We investigated the tolerability, safety, and treatment response to flexible-dose paliperidone ER in patients with non-acute schizophrenia in whom previous antipsychotic drugs were ineffective. Methods This 24-week interim analysis of the 48-week multicenter, prospective, open-label study assessed effectiveness using the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression-Schizophrenia-Severity (CGI-SCH-S) Scale, Personal and Social Performance (PSP) and Drug Attitude Inventory (DAI). Safety and tolerability were assessed using the Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) and Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS). Results Effectiveness was assessed in 169 patients. Significant improvement in the PANSS total score was observed by week-1 and continued until week-24. The response rate was 33%. The CGI-SCH-S and PSP total scores significantly improved during 24 weeks ; however, no change occurred in the total DAI. Fifty-nine percent of patients reported adverse events, of which extrapyramidal symptoms were the most frequent (19.0%). The DIEPSS and LUNSERS scores were improved after 24 week. Conclusions Switching to the flexible-dose paliperidone ER from an ineffective antipsychotic drug was safe, tolerable, and showed a good treatment response in Korean patients with schizophrenia.

Keywords

References

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